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Neutropenia clinical trials

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NCT ID: NCT05910164 Active, not recruiting - Clinical trials for Patient Satisfaction

Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim

PELGRAZ
Start date: June 9, 2023
Phase:
Study type: Observational

Febrile neutropenia (NF) is a common serious complication of cancer chemotherapy. Outpatient management of chemotherapy treatments is made essential by the volume of patients treated, respect for their quality of life and the lack of hospitalization resources. The prevention of NF is well documented and its success depends on the risks of developing NF related to the type of chemotherapy protocol used and the profile of the patient and his disease. Pegfilgrastim (G-CSF, biosimilar medicine) injection has been shown to prevent (febrile) neutropenia. It is routinely prescribed on an outpatient basis for patients treated with chemotherapy (CT), several thousand times a year in our geographical area. In order to take into account patient preferences and help clinical decision-making, this study will be conducted on the basis of self-administered questionnaires. The aim of the research is to assess patient preference for receiving administration of PELGRAZ (Accord Healthcare) using a prefilled syringe or a prefilled pen device. In a second step, this study will evaluate the learning of the patient and his autonomy during a pen self-injection guided by a nurse.

NCT ID: NCT05180838 Active, not recruiting - Clinical trials for Hematologic Malignancy

Remote Temperature Data for Early Detection of Febrile Neutropenia

Start date: October 7, 2021
Phase:
Study type: Observational

BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of ~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.

NCT ID: NCT04904614 Active, not recruiting - Neutropenia Clinical Trials

Letermovir Use in Heart Transplant Recipients

Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

This is an open label trial in which letermovir will be given as prophylaxis for the prevention of CMV infection and disease to all heart transplants who are at risk for cytomegalovirus. The study will compare a 30 patient prospective cohort to a retrospective cohort of 374 heart transplant recipients for the rates of neutropenia. In addition, the tolerability of letermovir will be assessed in this population.

NCT ID: NCT04250038 Active, not recruiting - Pharmacokinetics Clinical Trials

Association of Cefepime Trough Levels With Clinical Efficacy and Neurotoxicity in Patients With Febrile Neutropenia

Start date: August 1, 2019
Phase:
Study type: Observational

In this prospective monocenter observational study, the objective was to determine a safe and effective therapeutic window for cefepime in patients with neutropenic fever.

NCT ID: NCT04187898 Active, not recruiting - Breast Cancer Clinical Trials

Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer

Start date: March 11, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.

NCT ID: NCT04154488 Active, not recruiting - Neutropenia Clinical Trials

A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders

Start date: October 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a 2-part study of mavorixafor in participants diagnosed with chronic neutropenia. The main goal of Part 1 (Phase 1b) is to help researchers learn more about how the investigational medicine, mavorixafor, impacts people living with chronic neutropenia (including congenital, idiopathic, and cyclic). In Part 2 (Phase 2), the safety and tolerability of chronic dosing of mavorixafor will be evaluated in a larger participant population and the impact of 6-month chronic dosing of mavorixafor on participant neutropenia.

NCT ID: NCT04099901 Active, not recruiting - Multiple Myeloma Clinical Trials

Anakinra: Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT - A Randomized Controlled Trial

AFFECT-2
Start date: November 4, 2019
Phase: Phase 2
Study type: Interventional

Oral and intestinal mucositis are major risk factors for the occurrence of fever during neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These complications often require dose reductions or cause delay of treatment, and thereby interfere with optimal anticancer treatment. Currently, there are no effective strategies to prevent or treat mucositis and the related complications. The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown to be pivotal in the pathogenesis of mucositis and recently, it has been established in murine models that IL-1 inhibition significantly ameliorates chemotherapy-induced intestinal mucositis. The investigators recently conducted a phase IIa study (AFFECT-1, NCT03233776) studying the safety and maximum tolerated dose of anakinra, a recombinant human IL-1 receptor antagonist in adult patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (ASCT) who are at high risk for experiencing mucositis and fever during neutropenia (FN). Since treatment with anakinra has shown to be safe in this study population, the investigators will continue with a double-blind randomized placebo-controlled multicenter phase IIb trial to establish efficacy in the management of fever during neutropenia and mucositis.

NCT ID: NCT03333486 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer

Start date: December 7, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient?s immune cells and help destroy any remaining cancer cells.

NCT ID: NCT03294577 Active, not recruiting - Clinical trials for Chemotherapy-induced Neutropenia

Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia

Start date: October 23, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and cyclophosphamide (TAC) + combination plinabulin/pegfilgrastim Severe neutropenia is an absolute neutrophil count (ANC) <0.5 × 10^9/L. Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this study.

NCT ID: NCT02544685 Active, not recruiting - Cancer Clinical Trials

Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients

FENSY
Start date: July 2010
Phase: Phase 2
Study type: Interventional

Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the main sources of infections during neutropenia. Competitive inhibition of gut mucosal colonization by pathogenic microorganisms using synbiotics could represent one of the potential options for its prevention. Synbiotics represent combination of two components: probiotics and prebiotics. Probiotics are live microorganisms, which in form of drugs or food supplements administered at a sufficient dose help to maintain health beneficial microbial balance in the digestive tract of a human or other host. Prebiotics are food ingredients nondigestible for our digestive enzymes, but can be fermented by bacteria in our bowel and this way selectively stimulate growth or activity of specific saccharolytic bacterial strains. These changes in composition of our microflora may bring benefits on host well-being and health. Based on the results of human and animal studies, probiotics probably can not only decrease the level of gut colonisation with pathogenic bacteria, but may also lead to reduction in the duration of neutropenia, accelerate the restitution of the intestinal mucosa and boost immunity. Despite a significant number of studies on probiotics still only little evidence of their safety especially in immunocompromised patients is available. To help find new options for increasing quality of healthcare for children cancer patients and also to evaluate safety of this new approach investigators designed double-blinded placebo controled multicenter study aimed to decrease the number of febrile episodes using prevention with synbiotic.